UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054923 |
|---|---|
| Receipt number | R000062673 |
| Scientific Title | Development of the exercise program that applies group cognitive behavioral therapy for care prevention: A pilot study |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2025/03/27 11:42:28 |
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Basic information
Public title
Research on the development of new programs for preventing frailty
Acronym
Kokokara Genki Class
Scientific Title
Development of the exercise program that applies group cognitive behavioral therapy for care prevention: A pilot study
Scientific Title:Acronym
Kokokara Genki Class
Region
| Japan |
Condition
Condition
Normal older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to group guidance on exercise and nutrition, a psychological programme aided by group cognitive-behavioural therapy will be implemented for three months in a care prevention class for older adults with poor exercise habits. The effects of programme participation on lifestyle habits, such as the amount of physical activity in daily life, exercise habits and diversity of food intake, and on the drop-out rate will be examined. Furthermore, the implementation of the programme will be investigated after six months to determine its medium-term effects on reversion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exercise frequency
Key secondary outcomes
Physical activity (IPAQ-SF), Dietary Variety Score, frailty, motivation (J-DAS), mental health (J-WHO-5), depression (GDS-15), loneliness (UCLA Loneliness Scale), self-efficacy, frequency of interpersonal interaction, frequency of outings, social network (Japanese version of Lubben Social Network Scale), programme satisfaction (Japanese version Client SatisfactionQuestionnaire-8), instrumental activities of daily living
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Exercise and nutrition courses and cognitive behavioral therapy programs
Interventions/Control_2
Exercise and nutrition course only
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Participants aged 65 or over at the time of registration.
2.Participants who exercise less than once a week on a regular basis for 60 minutes at a time.
3.Participants who have obtained written consent from the individual after being explained the details of the study using the consent explanation document.
Key exclusion criteria
1. Participants who need to prohibit or restrict exercise, eating and drinking due to severe functional impairment (including osteoarticular diseases, renal failure, ischaemic heart disease and cardiopulmonary dysfunction)
2. Participants who are unable to speak Japanese.
3. Participants who have been assessed as requiring nursing care 1 or more. 4. subjects with major depression or bipolar disorder.
4. Participants with a history of major depression, bipolar disorder, schizophrenia, alcohol dependence or other drug dependence, serious illness or unstable condition
5. Participants whom the principal investigator considers to be unsuitable for the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mari |
| Middle name | |
| Last name | Yamashita |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
yama0531@tmig.or.jp
Public contact
Name of contact person
| 1st name | Mari |
| Middle name | |
| Last name | Yamashita |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Promoting Independence and Mental Health
Zip code
173-0015
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
TEL
03-3964-3241
Homepage URL
yama0531@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
Meiji Yasuda Life Foundation of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute of Gerontology
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo
Tel
03-3964-3241
yama0531@tmig.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
69
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062673
